BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY

    MDR report key: 3863884 · Received June 10, 2014

    Report

    Report Number
    1000165971-2014-00336
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 6, 2014
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    PP950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY ANALYSIS REVEALED A FAILURE (DAMAGE) AT THE LEVEL OF A COMPONENT THAT COULD EXPLAIN AN OVERCONSUMPTION OF THE DEVICE.

    Description of Event or Problem · 1

    REPORTEDLY, DURING A REGULAR FOLLOW-UP PERFORMED ON (B)(6) 2014, IT WAS FOUND THAT THE DEVICE HAD ALREADY REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) AND BATTERY IMPEDANCE WAS AT 12.5 KOHM. THE PREVIOUS FOLLOW-UP WAS PERFORMED A YEAR AGO ((B)(6) 2013) AND SHOWED A BATTERY IMPEDANCE OF 2.97 KOHM WITH A TIME TO ERI OF 21 MONTHS. SINCE TIME TO ERI WAS DISPLAYED AS 21 MONTHS AT THE PREVIOUS FOLLOW-UP, THE NEXT FOLLOW-UP (THIS FOLLOW-UP) WAS SCHEDULED ONE YEAR LATER AT THAT TIME. PHYSICIAN EXPLANTED THE DEVICE ON (B)(6) 2014 AND IT WILL BE RETURNED FOR ANALYSIS. AT RE-OPERATION, THE DEVICE WAS INTERROGATED AND BATTERY IMPEDANCE WAS AT 12.8KOHM.

    Description of Event or Problem · 1

    REPORTEDLY, DURING A REGULAR FOLLOW-UP PERFORMED ON (B)(6) 2014, IT WAS FOUND THAT THE DEVICE HAD ALREADY REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) AND BATTERY IMPEDANCE WAS AT 12.5 KOHM. THE PREVIOUS FOLLOW-UP WAS PERFORMED A YEAR AGO ((B)(6) 2013) AND SHOWED A BATTERY IMPEDANCE OF 2.97 KOHM WITH A TIME TO ERI OF 21 MONTHS. SINCE TIME TO ERI WAS DISPLAYED AS 21 MONTHS AT THE PREVIOUS FOLLOW-UP, THE NEXT FOLLOW-UP (THIS FOLLOW-UP) WAS SCHEDULED ONE YEAR LATER AT THAT TIME. PHYSICIAN EXPLANTED THE DEVICE ON (B)(6) 2014 AND IT WILL BE RETURNED FOR ANALYSIS. AT RE-OPERATION, THE DEVICE WAS INTERROGATED AND BATTERY IMPEDANCE WAS AT 12.8KOHM.

    Description of Event or Problem · 1

    REPORTEDLY, DURING A REGULAR FOLLOW-UP PERFORMED ON (B)(6) 2014, IT WAS FOUND THAT THE DEVICE HAD ALREADY REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) AND BATTERY IMPEDANCE WAS AT 12.5 KOHM. THE PREVIOUS FOLLOW-UP WAS PERFORMED A YEAR AGO ((B)(6) 2013) AND SHOWED A BATTERY IMPEDANCE OF 2.97 KOHM WITH A TIME TO ERI OF 21 MONTHS. SINCE TIME TO ERI WAS DISPLAYED AS 21 MONTHS AT THE PREVIOUS FOLLOW-UP, THE NEXT FOLLOW-UP (THIS FOLLOW-UP) WAS SCHEDULED ONE YEAR LATER AT THAT TIME. PHYSICIAN EXPLANTED THE DEVICE ON (B)(6) 2014 AND IT WILL BE RETURNED FOR ANALYSIS. AT RE-OPERATION, THE DEVICE WAS INTERROGATED AND BATTERY IMPEDANCE WAS AT 12.8KOHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338948 SYMPHONY PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN CRM SYMPHONY DR 2550 M071025

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention